CGMP Compliance

A specialized staff supervises the compliance with cGMP standards requirements for all the organization. This team manages the different elements of the quality system, including:

  • Validation Master Plan
  • Internal Audits
  • Investigation of process deviation
  • Complaints and OOS
  • Change controls
  • SOPs
  • Training
  • Raw material suppliers’ qualification

Our facilities are regularly inspected by our clients and have been routinely inspected by different authorities.

FDA inspected
since
Latest FDA
inspection
Other inspections Activity
CATALANA 1984 May 2013 AEMPS (Oct 2014),
K-FDA, JA
Generics CM
CANTABRA 2010 March 2012 AEMPS (Feb 2015)
TGA, JA
Generics CM
COPRIMA 2001 Nov. 2012 AEMPS (Dec 2012),
JA, Cofepris
Generics
MOEHS BCN AEMPS (Jan 2014) Generics CM
BENECHIM 2013 June 2013 AFMPS (Jan 2015) -
Belgium, JA
CM Generics
NORCHIM 1989 June 2012 AFFSAPS-France (Dec 2014), JA Process Research CM
C.F. BERG  2002 April 2012  BfArM-Germany (Dec 2014)
K-FDA, JA
Generics CM
PROTEOS BIOTECH  AEMS Biotechnology
*JA: Japanese Accreditation